Long-term safety and efficacy of lacosamide and controlled-release carbamazepine monotherapy in patients with newly diagnosed epilepsy
Epilepsia Dec 04, 2019
Ben-Menachem E, Grebe HP, Terada K, et al. - Given that lacosamide has been shown noninferior to controlled-release carbamazepine (carbamazepine-CR) with regard to efficacy and displayed good tolerability as first-line monotherapy in patients (≥ 16 years of age) with newly diagnosed epilepsy in a large-scale, double-blind trial (SP0993; NCT01243177), researchers describe primary safety results from the double-blind extension of the noninferiority trial (SP0994; NCT01465997) and analyzed pooled long-term safety and efficacy data from both trials by conducting post hoc analyses. Using randomization 1:1, the patients were administered lacosamide or carbamazepine-CR. Depending on seizure control, the escalation of doses was done (lacosamide: 200/400/600 mg/d; carbamazepine-CR: 400/800/1200 mg/d). In the extension, randomized treatment was continued in eligible patients. The initial trial involved the treatment of 886 patients and 548 were treated in the extension. The extension was completed by 211 of 279 patients (75.6%) on lacosamide and 180/269 (66.9%) on carbamazepine-CR. Findings revealed the efficacy as well as the general good tolerability of long-term (median ~2 years) lacosamide monotherapy in adults with newly diagnosed epilepsy. Both lacosamide and carbamazepine-CR offered similar seizure freedom rates.
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